HeartLogix HLI Heart Monitor Patient Instructions To activate your monitor or for questions call 1-855-751-3131
Contents of Kit HeartLogix Monitor Case e holter Monitor Case Holster Battery Charger Patient Cable Electrodes Device Battery 2
Monitor Overview Charger port Color display Up key Right key Patient cable connector Select key Left key Down key The display is not a touch screen; do not press on the display, as it may damage the device. Selections There are five are made blue lights by choosing that can one appear of the while four directional you are wearing keys and the the monitor. center The select lights key, indicate located where beside the the buttons color display are screen. located Use on the directional monitor. to They move only to appear the appropriate when you selected need to item, make then a press selection. center You select need button. to use the blue light buttons to move to the appropriate selection on the display, and then select that item by touching the blue light center button. Patient event button Serial number Battery door 3
Setting up the Monitor 1. Slide the battery door open and insert the rechargeable battery. Please follow instructions carefully to avoid damaging the device! Insert battery by aligning the rectangular holes on the front side of the battery with the pegs inside the battery compartment (fig. 1) fig. 1 Press the back of the battery down into the case (fig. 2) fig. 2 2. Replace the battery door. 3. If the screen doesn t come on, plug in your device to fully charge the battery. You may continue to set up the monitor while it s charging. The battery can be recharged in the device without interrupting the data recording. It s a good idea to pick the same time every day to recharge your monitor for one hour. (fig. 3) 4. Insert patient cable in the side of the monitor. (fig. 4) 5. Please select New Study and move onto Skin preparation and electron placement.
Battery Charger connector (gently lift tab) Patient Cable fig. 3 Battery Charger fig. 4
Skin Preparation & Electrode Placement 1. Skin Preparation Look at the picture on your monitor, it will show colored circles where the electrodes should be placed on your skin. The end of each lead has a different color. Shave the location if hairy. Cleanse location with soap and water or alcohol wipes. Dry skin completely. Do not use powder or lotion. CHEST 2. Electrode Placement Snap each of the lead wires from the patient cable onto a fresh electrode patch (latex free). Place in-between ribs (not directly over the bone). See diagram for placement instructions Once electrode is applied to your skin, do not pull on, loosen, or pull it off and reuse it; the adhesive won t work twice.
3. You do not need to remove these electrodes when you shower or bathe, however you must always disconnect the monitor and lead wire from the electrodes prior to showering or bathing. When you are ready to reconnect the monitor simply pat the electrodes dry and reconnect the lead wire. 4. Replacing electrodes Every 48 hours you ll need to replace your electrodes. Remove lead wires from electrodes on your chest. The monitor will show the following message: Remove electrodes, wash off excess gel, and dry completely. Place new electrodes in proper locations. (They don t need to be on the exact same spot.) Avoid placing any electrodes on irritated skin. If you experience irritation, please call the 24-hour call center at 1-855-751-3131 800.574.1395 7
Capturing Patient Cardiac Symptoms 1. Sit quietly. Press and hold the event button for three seconds. Release the button. 2. Record your symptoms and activities, remove the monitor from the case and follow directions on the next page. Even if you don t add symptoms or activities, the monitor will automatically transmit the data (if you are within the range of a cellular network,) within a few minutes. If you are not in range, the monitor will continue to check the network until it is able to send the data. The monitor will save the data until you are in range. Remember that if you experience severe symptoms, such as chest pain, you should immediately contact emergency services!
Recording Symptoms: Scroll up or down to find the appropriate symptom. Push the center blue light to select it. Recording Activity: Scroll up or down to find the appropriate activity. Push the center blue light to select it. Automatically Detected Events 1. If your physician has determined your monitor should automatically detect changes in your heart rhythm, then the monitor will be operating in auto-detection mode. This means the monitor will continuously evaluate your heart rhythms and save events per your physician s orders. 2. When the monitor recognizes an event, it will capture the event and automatically transfer it, (if you are within range of the cellular network). If you are not in range, the monitor will continue to check the network until it is able to send the data. The monitor will save the data until you are in range. 9
Returning Your Monitor 1. Near the end of your test period, you will receive a message to remind you to return the monitor. 2. Prior to returning the monitor, remove the patient cable and make sure all the data has transmitted, and the event counter on the display is zero. If not, please go to a location with adequate cell coverage to allow the remaining data to transmit. 3. Unplug the patient lead wire and remove the battery. 4. Place the monitor, lead wire, battery, and battery charger into the black case. 5. Return the case to your physician as soon as possible. Please note: the monitor is the property of your physician and must be returned immediately upon termination of your service. You are financially responsible and will be billed for the cost of the monitor if it is damaged, lost, or not returned 10
Warnings and Precautions Patient Use precautions: Heartlogix The e holter monitor contains sensitive electronic circuitry. Please observe the following precautions while using the monitor. Failure to do so may result in serious damage to the device. Avoid exposure to moisture The monitor should not be used while swimming, showering, bathing, or participating in any aquatic activities. Use caution to avoid inadvertent submersion in water. Avoid sharp impacts While the monitor has been designed to survive minor drops, it is possible to damage the internal structure or outer casing if the device suffers a sharp impact or is otherwise traumatized. In case of damage, call 800.574.1395 your Physician? Avoid pulling on wires Always disconnect cables from the device by grasping the rubberized connector, not by pulling directly on the wire. Yanking on the wires may result in irreparable damage to the cables. Avoid electromagnetic interference Stay away from heavy electrical equipment or other sources of electromagnetic interference. This includes household items, such as an electrical blanket and heating pad. Patient responsibilities: As the patient you are expected to fulfill the following responsibilities while using the monitor in order to ensure proper detection and analysis of your heart s symptoms. 11
Keep electrodes connected The monitor can only record data when it is properly connected to the electrodes on your body. The device will emit a short beep whenever it detects one of more of the electrodes has become disconnected. If any of the electrodes become disconnected, the monitor will stop recording and prompt you to reconnect them. Keep the Battery Charged The monitor can record for 24 hours on a single battery charge. Connect the provided wall charger to the charger port on the device to recharge the batter when wearing the monitor for more than 24 hours. You many keep the monitor connected to the electrodes so it can continue to record data while it is recharging. Only use the charger provided by e holter. Report any cardiac-related events Hold the event button, located opposite the cable connector on the device for three seconds to mark when you fell any heart-related symptoms. Equipment symbols: Consult the Directions for Use Type B Device Eletrically Isolated Manufacturer Info Prescription Only Wireless Device 12
Frequently Asked Questions Q. What happens when I do not have a good cell signal? A. The information collected by the monitor will be stores and the monitor will automatically resend the information once you are back in range. Q. Can I wear the device while I am showering, bathing, or swimming? A. No. The monitor is not waterproof. Before showering or bathing, disconnect the lead wire from the electrodes. You can wear the electrode patches in the water, but towel dry them when you have finished. Check to make sure they are still well adhered to your skin prior to reattaching the lead wires. Q. How will I know the results of my testing? A. The physician who ordered your test will be given the results and he/ she will review the results with you at the end of your testing period. Q. When will my physician be told how I am doing? A. Your physician has given us specific instructions as to when we should contact them. Q. How many days will I need to wear the monitor? A. The testing period is determined by your physician. You will be told how long to wear the monitor when you call to activate it.
Frequently Asked Questions Q. How will I know when the testing is complete? A. You will be told at the start of service when you call to activate your monitor. You will also get a message toward the end of the test period or earlier if your physician has received enough data. Q. Will I be charged for this monitor? A. The monitor is is the the property of e of holter The Physician and on loan and to on you. loan It must to you. be It must returned be returned promptly via promptly UPS. You as will instructed only be charged by your if Physician. the monitor You is not will only returned be charged or is damaged. if the monitor is not returned or is damaged. Caution: US Federal law restricts the use of this monitor unless prescribed by a physician. 14
Detailed Monitor Information The Monitor: Battery-operated ambulatory electrocardiograph recorder for use in cellular event monitoring or mobile cardiovascular telemetry monitoring capable of storing three channels of patient ECG data acquired from three or five surface electrodes adhered to the body. Can record data for over 30 days of continuous recording with a rechargeable lithiumion battery to achieve such an extended recording duration. Can automatically detect and record pacemaker pulses as well as several common arrhythmias in accordance with the appilicable standards of the Association for the Advancement of Medical Instrumentation. Contains an internal cellular modem to allow access to the patient ECG data. Any piece of data recording on the device may be queried wirelessly during the course of the study. Additionally, data transmissions may be triggered automatically or manually as a result of arrhythmia analysis or manual patient input, respectively. Provides a multitude of options to control recording parameters, such as bit resolution, sample resolution, sampling rate, and frequency response; also provides analysis parameters, such as heart rate thresholds. These settings may be updated wirelessly during the course of a study to allow the device to dynamically adapt to the needs of the operator. Does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibilities of a trained healthcare professional or physician. Indications for Use: The monitor is intended tor acquiring ambulatory ECG signals from patients who are either at risk of, or have, cardiac disease, or have intermittent symptoms indicative of cardiac disease who have demonstrated a need to be monitored on a continuing basis. Indications for conducting ambulatory recording including patients requiring monitoring for: Non life-threatening arrhythmias such as supraventricular tachycaridas and ventricular ectopy. Evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardicvascular surgery and myocardial infarction. Arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. Experiencing symptoms such as syncope of unknown etiology or shortness of breath, which may be due to cardiac arrhythmias. Palpitations with or without unknown arrhythmias to obtain correlation of arrhythmias with symptoms. The effects of drugs to control ventricular rate in atrial arrhythmias. Recovering from cardiac surgery when they are indicated for outpatient arrhythmia monitoring. With diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias. Arrhythmia evaluation of etiology or stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter. Data from this device may be used by another device to analyze, measure, or report QT interval. The device is not intended to sound any alarms for QT interval changes.
Contraindications: The monitor is not intended for use under the following contidions: Infants weighing less than 10 kg. (22 lbs.) Patients with potentially life-threatening arrhythmias who require inpatient monitoring. Patients who the attending physician thinks should be hospitalized. Federal Communications Commission (FCC) ID: ZIMTZMR FCC Compliance Statement The FCC has adopted a safety standard for human exposure to radio frequency (RF) electromagnetic energy emitted by FCC-certified equipment. This wireless electro-cardiovascular monitor has been evaluated under FCC Bulletin OET 65C (01-01) and found to be compliant to the requirements of uncontrolled environmental limits as set forth in CFR 47 Sections 2.1091, 2.1093 addressing RF exposure from radio frequency when operated in accordance with the operation guidelines described in this manual. Proper operation of this radio device according to the instructions of this publication will result in user exposure substantially below the FCC recommended limits. The monitor contains a radio transmitter and receiver. It is designed and manufactured not to exceed the limits for exposure to RF energy set by the Federal Communications Commission of the U.S. Government. These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population. The guidelines are based on standards that were developed by independent scientific organizations through periodic and thorough evaluation of scientific studies. The standards include a substantial safety margin designed to assure the safety of all persons, regardless of age and health. The exposure standard for wireless mobile devices employs a unit of measurementknown as the Specific Absorption Rate or SAR. The SAR limit set by the FCC is 1.6W/kg. Tests for SAR are conducted using standard operating positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency bands. Although the SAR is determined at the highest certified power level, the actual SAR level of the device while operating can be well below the maximum value. This is because the device is designed to operate at multiple power levels so as to use only the power required to reach the network. In general, the closer you are to a wireless base station antenna, the lower the power output. Before a device model is available for sale to the public it must be tested and certified to the FCC that it does not exceed the limit established by the government-adopted requirement for safe exposure. The tests are performed in positions and locations (for example, worn on the body) as required by the FCC for each model. This device has been tested and meets FCC RF exposure guidelines when worn on the body using the monitor s leather carrying case. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. The highest reported SAR value for this body-worn device is: 0.799W/kg. The FCC has granted an equipment authorization for this wireless electro-cardiovascular monitor with all reported SAR levels evaluated as in compliance with the FCC RF exposure guidelines. SAR information on this device is on file with the FCC and can be found under the Display Grant section of: http://transition.fcc.gov/oet/ea/fccid/ after searching on FCC ID: ZIMTZMR 16
Device Specifications Functional ECG Channels 3 Sample Rate 256 or 512 Samples per Second User Interface Color graphic display with direction pad and select Memory Total Recording Time 30 Days Maximum Event Duration 11 Minutes Media microsdhc card* Physical Case Dimensions 4.25 x 2.70 x 0.89 inches (108 x 68.8 x 22.6 mm) Weight with Battery 6.4 oz. (181 g) Electrical Input Impedance >10M Ohms CMRR >60 db AC Signal Range ± 6 mv DC Signal Range ± 300 mv Resolution 3 µv (12 bits) Frequency Response 0.05 Hz to 40 Hz (default) [LPF adj: 30 Hz 100 Hz] Pacemaker Detection ANSI/AAMI EC38:2007 Environmental Operating Temperature 0 C (32 F) to 50 C (122 F) Operating Humidity 10% to 95% non-condensing Storage Temperature -20 C (-4 F) to 70 C (158 F) Storage Humidity 5% to 95% non-condensing Operating Shock 75mm drop on a hard surface Vibration 10 minutes, 3 axis, 0.3G RMS to 500 Hz, random Wireless Transmission Service GPRS/EGPRS Bands 850/900/1800/1900 MHz Battery Type Single Cell, Lithium-Ion Rechargeable Life 24 to 48 hours, from full charge 17
Additional equipment classification information as required in EN 60601-1 EQUIPMENT not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE IPX0-Ordinary Equipment (enclose equipment without protection against egress of water) Internally Powered Equipment Mode of Operation Continuous Conformance to Regulartory Standards TZ Medical, Inc. Declares that this device complies with the essential requirements of Article 3 of the R&TTE 199/5/EC Directive, if used for its intended use and that the following standards have been applied: BSEN 62209-2: 2010 ETSI EN 301 489-1 V1.8.1 ETSI EN 301 489-7 V1.3.1 ETSI EN 301 511 V9.8.2 International Electrotechnical Commission (IEC) IEC 62209-2: 2010 American Advancement of Medical Instrumentation (AAMI) ANSI/AAMI EC38:2007 18